MAUDE Adverse Event Report: LUMENIS BE LTD ULTRAPULSE; CARBON DIOXIDE SURGICAL LASER DELIVERY DEVICE

Model Number	ULTRAPULSE
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting with customer representative, since no account name nor serial number of a system was provided.Attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information and patient photo.Treatment setting has been provided to lumenis.There is no allegation of a system malfunction.The customer asked a question regarding correctness of the settings used, but didn't provide the account name or serial number of the system, despite of lumenis requirement for details.Therefore, the system hasn't been checked.Provided treatment settings have been sent to the clinical healthcare director that concluded: "settings are not suitable at all for a décolletage.They are full resurfacing mode for the most sensitive body part.It is a user error undoubtedly." during further clarification, clinical director added: "on off face areas, co2 is to be used with extra caution and in a conservative approach.Of course, knowledge of settings would allow to get a better picture but from the received info, i can say: 1) two passes - even if mild - are definitely not recommended in our guidelines for off face areas 2) development of a keloid post-op constituting a permanent impairment, yes, the injury should be classified as serious and therefore reportable".According to the information received there was no allegation of a device malfunction.Since the customer didn't provide detailed information to lumenis, only the settings used were provided, a clinical evaluation was performed only based on the settings provided.According to clinical director, there was a user error.Settings are not suitable at all for a décolletage.Two passes - even if mild - are definitely not recommended in our guidelines for off face areas.Moreover, development of a keloid post-op constituting a permanent impairment.Based on 1001481_r ultrapulse and ultrapulse duo risk analysis - section #1.3.4.1 - using wrong set of parameters or poor understanding of system functions, the risk is within the acceptable risk.Finally, the hazard severity was rated by clinical director as serious injury.Therefore, this case was determined as reportable to the fda.However, since there was a user error not due to ergonomic features, this case is not reportable to eu authorities.Per the eu mdr, user errors are only reportable to the eu authorities if they happened due to ergonomic features.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.Lumenis is closing this complaint but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4)) and per post marketing surveillance procedure (doc no.(b)(4)).
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained keloid at the décolleté area following treatment by ultrapulse device.

• Brand Name: ULTRAPULSE
• Common Device Name: CARBON DIOXIDE SURGICAL LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer Contact: yossi avnilov ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 20814861
• Report Number: 3021349626-2024-00014
• Device Sequence Number: 9940633
• Product Code: GEX
• UDI-Device Identifier: 07290109141596
• UDI-Public: 07290109141596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 12/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: ULTRAPULSE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown